pilot accelerated theta burst in treatment-resistant bipolar depression

Conditions: Treatment Resistant Depression

Summary: this study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. in this open-label study, all participants will receive accelerated theta-burst stimulation.

repetitive transcranial magnetic stimulation (rtms) is an established technology as therapy for treatment-resistant depression. the approved method for treatment is 10hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (l-dlpfc). this methodology has been very successful in real-world situations. the limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session over 4-6 weeks). recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. in a recent study, the investigators applied this accelerated paradigm in individuals with treatment-resistant depression (trd), which showed a significant antidepressant effect (90% remission rate). additionally, 3 participants from this study carried a bipolar trd diagnosis and responded at minimum, equally as well, with no adverse events experienced or manic/hypomanic conversion observed during the treatment series. this study intends to further modify the parameters to create a more rapid form of this treatment for bipolar trd, and look at the change in clinical measures and neuroimaging biomarkers.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 80 years of age. * able to provide informed consent. * diagnosed with bipolar disorder and currently experiencing a major depressive episode (mde). * meet the threshold on the total madrs score of \>/=20 at baseline. * in good general health, as ascertained by medical history. * if female, a status of non-childbearing potential or use of an acceptable form of birth control. * history of rtms failure with fda approved rtms parameters is permitted. exclusion criteria: * female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. * female that is pregnant or breastfeeding. * female with a positive pregnancy test at participation. * total madrs score of \< 20 at study entry. * current diagnosis of a substance use disorder (abuse or dependence, as defined by dsm-iv-tr), with the exception of nicotine dependence. * current diagnosis of axis i disorders other than dysthymic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, or specific phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more). * history of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes. * any axis i or axis ii disorder, which at screening is clinically predominant to their bipolar depression or has been predominant to their bipolar depression at any time within six months prior to screening. * considered at significant risk for suicide during the course of the study. * has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results. * participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation. * any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. * history of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates. * current (or chronic) use of opiates. * history of epilepsy. * history of shrapnel or metal in the head or skull. * history of cardiovascular disease or cardiac event. * history of ocd. * history of autism spectrum disorder. * current psychosis * any change in medication of which the study pi is not aware of.

Keywords: bipolar disorder treatment resistant depression transcranial magnetic stimulation (tms) theta burst